16629 – Deviation Management Specialist – Dublin Contractor

This is a 11 month contract with a view to extension

Purpose

The Quality Deviations Specialist ensures adherence to Good Manufacturing and Documentation Practices and local procedures.
Ensure that the QA team objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities

• Serve as support Quality SME for site deviation management system.
• Support the review and approval of site deviation and investigations reports.
• Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
• Day to day management of Deviation and CAPA metrics.
• Support internal and external audit preparations regarding deviation management system.
• Support the delivery of site deviation training.
• Support global meetings and activities for site deviation management system.
• Works directly with cross-functional departments to ensure that quality system requirements are met.
• Performs other duties assigned by Quality Management.

Minimum Qualifications/Experience

• Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline
• 3 years experience in Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
• Experience working in regulated environment with exposure in the regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11.
• Must have at least 3 years’ experience with deviation systems and investigations.
• Must have experience of compiling and reporting QMS metrics.
• Experience with SAP enterprise system.
• Experience with new product introductions and/or process qualification/technology transfer.
• Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends relating to deviation investigations and CAPA identification.
• Technical writing skills.
• Lean Six-sigma and problem solving tools.